Efficacy of OmegaBoost to Increase Omega-3 Levels in Healthy Individuals
- Conditions
- Omega 3 IndexDry Eye SyndromesAge-Related Macular Degeneration
- Registration Number
- NCT05763940
- Lead Sponsor
- Western University of Health Sciences
- Brief Summary
The purpose of this study is to determine increases in the Omega Index test indicating optimal Omega-3s particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels for overall systemic benefits including healthy cardiovascular health and cholesterol levels as shown in the OmegaIndex (OmegaQuant) research.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- not currently taking Omega-3 supplements or fish oils
- able to swallow softgel or chew gummies nutritional supplement daily for a 12 week period
- able to make four (4) follow-up visits
- allergy to fish or seafood
- h/o Atrial fibrillation, or at risk of Afib
- h/o congestive heart failure, heart disease, or prior myocardial infarction and/or cerebrovascular accident
- noncompliance with study requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean Changes in Omega-3 Index (OmegaQuant) Baseline, 4 weeks, 8 weeks, and 12 weeks OmegaQuant provides Omega Index which is a percentage of omega 3 fatty acids particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the erythrocytes. The baseline values of OmegaIndex will be compared to repeated measurements obtained at at a 4-, 8- and 12-week. The OmegaQuant labs in Sioux Falls, SD analyze the blood samples to obtain omega-3 levels, omega-6 fatty acids, cis-Monounsaturated Fatty Acids, saturated fatty acids, trans fatty acids. Additionally, arachidonic acid to eicosapentaenoic acid ratio and omega 3 to omega 6 ratios will be calculated
Mean Changes in omega 3 to omega 6 ratios Baseline, 4 weeks, 8 weeks, and 12 weeks The baseline values of omega 3 to omega 6 ratios provided by the blood erythrocyte testing performed the OmegaQuant test will be compared to repeated measurements obtained at a 4-, 8- and 12-week.
- Secondary Outcome Measures
Name Time Method Mean changes to total cholesterol with Omega Boost supplementation Baseline, 4 weeks, 8 weeks, and 12 weeks For the once-daily group, baseline total cholesterol is evaluated and will be repeated at various time points that is 4 weeks, 8 weeks, and 12 weeks. The groups will be compared. A reduction or decrease in values over time is considered an improvement.
Mean changes to low-density lipoprotein with Omega Boost supplementation Baseline, 4 weeks, 8 weeks, and 12 weeks For the once-daily group, baseline low-density lipoprotein is evaluated and will be repeated at various time points which are 4 weeks, 8 weeks, and 12 weeks. The groups will be compared. A reduction or decrease in values over time is considered an improvement.
Mean Changes in General Health Questionnaire Baseline, 4 weeks, 8 weeks, and 12 weeks Eligible participants will be asked to complete the General Health Questionnaire during each visit to monitor secondary observational improvements and overall compliance. The questionnaire will assess: overall health \& wellbeing, overall mood, energy level, stress, mental focus, joint health; along with changes in skin, hair, nails, and dry eye (if applicable). With a lower score considered to be a worse outcome
Mean changes to Hb a1c with Omega Boost supplementation Baseline, 4 weeks, 8 weeks, and 12 weeks For the once daily group Baseline Hba1c is evaluated and will be repeated at various time points that is 4, 8 and 12 weeks. The groups will be compared. A reduction or decrease in values over time is considered an improvement.
Mean changes to triglycerides with Omega Boost supplementation Baseline, 4 weeks, 8 weeks, and 12 weeks For the once-daily group baseline triglycerides is evaluated and will be repeated at various time points which are 4 weeks, 8 week, and 12 weeks. The groups will be compared. A reduction or decrease in values over time is considered an improvement.
Mean changes to high-density lipoprotein with Omega Boost supplementation Baseline, 4 weeks, 8 weeks, and 12 weeks For the once-daily group baseline high-density lipoprotein is evaluated and will be repeated at various time points that is 4 weeks, 8 weeks, and 12 weeks. The groups will be compared. An increase in values over time is considered an improvement.
Trial Locations
- Locations (1)
Western University of Health Sciences
🇺🇸Pomona, California, United States
Western University of Health Sciences🇺🇸Pomona, California, United States